Institute Overview

• Ifakara Health Institute (IHI) is a leading research organization in Africa with a strong track record in developing, testing and validating innovations for health. Driven by a core strategic mandate for research, training and services, the Institute’s work now spans a wide spectrum, covering biomedical and ecological sciences, intervention studies, health-systems research, service delivery and policy translation.Position Summary
• Ifakara Health Institute is seeking a qualified Medical Doctor Specialist who will be stationed at Bagamoyo Office reporting to the Head of Biomedical Research and Clinical Trials. Medical Doctor Specialist will provides overall operational leadership and accountability for BCTF capability, trial readiness, safe facility operation and implementation of relevant ICH-GCP and local regulatory and ethical requirements for clinical trials facility. The Medical Doctor Specialist will integrates the scientific, clinical, participant, quality and resource functions of BCTF and ensures that significant risks, capability gaps and institutional-support requirements are addressed through the appropriate governance pathway. Through BRCT, the Medical doctor specialist will reports BCTF performance, strategic priorities, resource requirements, investment needs and unresolved institutional risks.

Responsibility:

• Ensure that each requirement has an accountable unit, competent personnel, approved controls and sufficient resources.
• Operate an approved BCTF governance structure defining unit ownership, reporting lines, delegated authority and escalation pathways
• Report significant capability, safety, quality and resource risks through BRCT, or other authorized pathways.
• Communicate approved decisions to accountable BCTF units and monitor implementation.
• Identify the IHI departments required for routine BCTF operations and each proposed trial.
• Review of the workforce, operating-budget, infrastructure, equipment and investment requirements prepared through Resource Management and Institutional Support Unit.
• Approve improvement priorities, responsible owners and timelines.
• Prioritize resource needs according to safety, compliance, trial pipeline, operational demand and sustainability.
• Submit major budget and investment proposals through BRCT.
• Review implementation and evidence status across BCTF regulatory and ethical requirements.
• Require documented readiness assessments from the units under BCTF.
• Reassess authorization following significant protocol, safety, staffing, facility or resource changes.
• Submit performance reports, strategic priorities, resource requirements, investment proposals and unresolved institutional risks through BRCT.
• Restrict, postpone or suspend BCTF activities where participant safety, data integrity, compliance or capability is compromised.
• Address onward communication where work is subcontracted or the sponsor does not own the IMP.
• Ensure the PI receives and reviews the quality, status and completeness of relevant safety information.
• Retain governance decisions, assigned actions and follow-up evidence.
• Ensure a formal sponsor agreement or internal memorandum specifies responsibility for immediate notification of new safety or toxicology information.
• Ensure the PI receives and reviews the quality, status and completeness of relevant safety information.
• Document risks, mitigations and evidence that mitigations were implemented.
• Assess each proposed trial, PI and research team before facility approval.
• Ensure the PI accepts imposed conditions and retain evidence that all conditions and mitigations were met.
• Monitor delivery and escalate failures affecting participant safety, data integrity, compliance or operational continuity.

Skill :

• Independent trial risk assessment and mitigation skills.
• Proactive and confident with strong ethics, ability to multitask meet deadlines.
• Competent in protocol and proposal development.
• Experience in resource prioritization, budget and investment review, quality assurance management and audit.
• Competence in trial design investigator brochure review, clinical risk assessment, starting dose and dose escalation review, stopping criteria, mitigating planning and PI/ tea, suitability assessment.
• Ability to recognize limits of personal expertise and obtain appropriately qualified specialist input.
• Experience with computer programs.
• Ethics, regulatory and assurance oversight
• Team worker, able to work in a multi culture environment, punctual and with high integrity.

Qualification Required:

• Medical degree with Post graduate qualification in medicine, health, Clinical research, public health, and health – service management or a related field.
• Professional registration.
• Current GCP training.

Experience :

• More than 3 years clinical research experience, with a strong understanding of clinical trials.
• Substantial leadership experience in clinical trials or regulated clinical research.
• A medical qualification is preferred where the Head is expected to exercise clinical authority.

Preferred Language Skill :

• Strong interpersonal skills and communication (Oral and written)

• Ensure that each requirement has an accountable unit, competent personnel, approved controls and sufficient resources.
• Operate an approved BCTF governance structure defining unit ownership, reporting lines, delegated authority and escalation pathways
• Report significant capability, safety, quality and resource risks through BRCT, or other authorized pathways.
• Communicate approved decisions to accountable BCTF units and monitor implementation.
• Identify the IHI departments required for routine BCTF operations and each proposed trial.
• Review of the workforce, operating-budget, infrastructure, equipment and investment requirements prepared through Resource Management and Institutional Support Unit.
• Approve improvement priorities, responsible owners and timelines.
• Prioritize resource needs according to safety, compliance, trial pipeline, operational demand and sustainability.
• Submit major budget and investment proposals through BRCT.
• Review implementation and evidence status across BCTF regulatory and ethical requirements.
• Require documented readiness assessments from the units under BCTF.
• Reassess authorization following significant protocol, safety, staffing, facility or resource changes.
• Submit performance reports, strategic priorities, resource requirements, investment proposals and unresolved institutional risks through BRCT.
• Restrict, postpone or suspend BCTF activities where participant safety, data integrity, compliance or capability is compromised.
• Address onward communication where work is subcontracted or the sponsor does not own the IMP.
• Ensure the PI receives and reviews the quality, status and completeness of relevant safety information.
• Retain governance decisions, assigned actions and follow-up evidence.
• Ensure a formal sponsor agreement or internal memorandum specifies responsibility for immediate notification of new safety or toxicology information.
• Ensure the PI receives and reviews the quality, status and completeness of relevant safety information.
• Document risks, mitigations and evidence that mitigations were implemented.
• Assess each proposed trial, PI and research team before facility approval.
• Ensure the PI accepts imposed conditions and retain evidence that all conditions and mitigations were met.
• Monitor delivery and escalate failures affecting participant safety, data integrity, compliance or operational continuity.

• Independent trial risk assessment and mitigation skills.
• Proactive and confident with strong ethics, ability to multitask meet deadlines.
• Competent in protocol and proposal development.
• Experience in resource prioritization, budget and investment review, quality assurance management and audit.
• Competence in trial design investigator brochure review, clinical risk assessment, starting dose and dose escalation review, stopping criteria, mitigating planning and PI/ tea, suitability assessment.
• Ability to recognize limits of personal expertise and obtain appropriately qualified specialist input.
• Experience with computer programs.
• Ethics, regulatory and assurance oversight
• Team worker, able to work in a multi culture environment, punctual and with high integrity.

• Medical degree with Post graduate qualification in medicine, health, Clinical research, public health, and health – service management or a related field.
• Professional registration.
• Current GCP training.